Inspection Readiness is a company’s commitment to establishing high-quality GxP-compliant processes and deliverables that meet regulatory requirements, to enable regulatory review of market applications of new therapies. While it is possible to begin this process at later stages of the drug development process, it is beneficial to establish high quality and regulatory compliance earlier and at all stages of the drug development process.
The main benefits of Inspection Readiness are non-compliance risk reduction, quality improvement, increased efficiency, better relationships with regulatory authorities, and enhanced industry and patient reputation. Inspection Readiness helps to ensure that clinical trials are compliant and within regulatory guidelines and regulations. As a result, clients find that process times and costs may be reduced, and patient safety and outcomes are better.
Our Approach
As one of our crucial services, RegDev integrates Inspection Readiness best practices with our other quality management services. We have partnered with many clients as they embark on late-stage drug development (and subsequent regulatory filing or market application of their products), but we believe that commitment to high-quality and regulatory compliance should begin earlier and weave throughout all stages of the drug development process.
HIGHEST STANDARDS OF QUALITY
COMMITMENT TO COMPLIANCE
INSPECTION READINESS
REDUCED RISK
SPONSOR/SITE READINESS
PROACTIVE SELF ASSESSMENT
REDUCED NON-COMPLIANCE RISK
Inspection Readiness helps ensure that clinical trials are conducted in compliance with regulatory requirements and guidelines, reducing the risk of non-compliance and associated penalties. Our consultants help foster a culture of compliance by ensuring that all stakeholders understand the importance of inspection readiness and their role in achieving it.
IMPROVED QUALITY, INCREASED EFFICIENCY
Inspection Readiness programs help ensure that clinical trials are conducted to the highest standards of quality, which can lead to improved patient safety and better outcomes. By proactively managing clinical trials to ensure the highest quality at each step of the process, and by paying greater scrutiny to high-risk areas, inspection readiness programs can help increase efficiency and reduce the time and cost associated with inspections.
BETTER RELATIONSHIPS, IMPROVED REPUTATION
Inspection Readiness programs help build better relationships with regulatory authorities by demonstrating a commitment to compliance and quality.
Testimonial
“It is not only the professionalism and high quality of the advice and work of the RegDev’s GCP and GMP teams, but, as importantly, the manner in which it is performed in tandem and through seamless integration with a company's internal stakeholders.”
